Livmarli: which tox species, and why?

“repeat-dose oral toxicology studies in rats for up to 6 months and in dogs for up to 12 months”

“Maralixibat has to be characterised as a substance of very low bioavailability, with a local mode of action. Overall, the study programme appears to be appropriate and complete, justifying from pharmacokinetic point of view the species involved in toxicity testing.”

“In the 26-week rat toxicity study, maralixibat at 750 mg/kg/day in males and 2000 mg/kg/day in females caused deaths due to bleeding, which was attributed to vitamin K deficiency.”